Evaluating the Efficacy and Safety of the Oral Polyherbal Drug Unani UNIM 301 as an Add On Therapy to Standard Care in Rheumatoid Arthritis A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 244
- 试验地点
- 1
研究概览
简要总结
This clinical study aims to evaluate the effectiveness and safety of the oral polyherbal Unani formulation UNIM 301 as an add on therapy to standard DMARD treatment in patients with mild to moderate rheumatoid arthritis. Participants will be assigned either to unani group having UNIM 301 plus Standard of Care DMARDs or control group of Standard of Care alone.
The study focuses on achieving remission or low disease activity, and preventing radiographic progression. The primary objectives are to compare the efficacy, safety, and relapse rates between the two treatment groups. The secondary objectives include evaluating the rapidity of clinical response and improvement in quality of life.
All participants will receive treatment for 16 weeks, followed by a 12 week post treatment follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Trial Participants of either sex, aged 18-65 years
- •Trial Participants with definite rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria.
- •Disease duration less than 5 years since persistent arthritis
- •Trial Participants having at least one swollen or tender joint
- •Trial Participants with DAS28 score more than 3.2 %.
排除标准
- •Pregnant and nursing patients
- •Trial Participants with severe anemia Hb level less than 13 g per dL in men; less than 12 g per dL in women
- •Trial Participants on corticosteroid therapy in the past 3 month
- •Trial Participants on biological therapy
- •Trial Participants resistant to treatment with more than three traditional DMARD’s
- •Trial Participants those in remission or with low disease activity
- •Significant cardiac, pulmonary & hepato renal dysfunction
- •Known cases of Hepatitis B, Hepatitis C, HIV or malignancies
- •Trial Participants unsure about attending treatment schedule regularly
- •Trial Participants having Gout, or complicated RA
- •Severe cases of RA Stage III & IV
- •Diagnosed cases of Ankylosing spondylosis.
研究者
Tamanna Nazli
CCRUM, MINISTRY OF AYUSH